Method of treating pediatric patients with corticosteroids

a corticosteroids and pediatric patient technology, applied in the field of topical corticosteroids, can solve the problems of linear growth retardation, adverse effects, and the use of topical steroids in the general population, and achieve the effects of low incidence of suppression of hpa-axis, and safe topically administered

Inactive Publication Date: 2007-08-02
MEDICIS PHARMA CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0017] According to the present invention, a class I steroid, such as fluocinonide, may be safely administered topically to pediatric patients once or twice daily, with little or no suppression of the HPA-axis. Fluocinonide compositions may be formulated at various potencies depending on the vehicle used and the amount of fluocinonide added to the composition. Fluocinonide (0.1% cream), formulated as a class I steroid, administered once daily does not result in suppression of the HPA-axis in patients 3 mont

Problems solved by technology

Pediatric patients may be more susceptible to systemic toxicity from the use of topical steroids because of their larger skin surface to body mass ratios.
The use of topical steroids in pe

Method used

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Examples

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embodiments

[0045] In one embodiment of the invention, the fluocinonide may be delivered in a vehicle comprising at least two penetration enhancers, including diisopropyl adipate, dimethyl isosorbide, propylene glycol, 1,2,6-hexanetriol, and benzyl alcohol.

[0046] According to another embodiment of the present invention, fluocinonide is combined with two or more penetration enhancers (preferably propylene glycol and at least one other penetration enhancer), and one or more solvents and emulsifiers for the corticosteroid and optionally penetration enhancers, wherein the penetration enhancers are present in ratio to the total of the penetration enhancers, and solvents and emulsifiers of at least about 0.70, preferably at least 0.80 and most preferably 0.90 or 0.95. Optionally, one or more inactive ingredients may also be combined with fluocinonide.

[0047] In order to determine the ratio, the following formula is used: (a:(a+b)) where “a” is the penetration enhancers and “a+b” is the sum of penetr...

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PUM

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Abstract

The present invention comprises a method of treating pediatric patients suffering from an inflammatory or pruritic skin disorder comprising topically applying fluocinonide to an affected area. Treatment according to this method does not result in clinically significant suppression of the HPA-axis.

Description

FIELD OF THE INVENTION [0001] Clinically, topical corticosteroids are useful for their anti-inflammatory, and anti-pruritic actions. Corticosteroids (or corticoids) are any steroids (lipids that contain a hydrogenated cyclopentoperhydrophenanthrene ring system) elaborated by the adrenal cortex (except sex hormones of adrenal origin) in response to the release of adrenocorticotrophin or adrenocorticotropic hormone by the pituitary gland, or to any synthetic equivalent, or to angiotensin II. [0002] The potency of topical steroid preparations is strongly correlated to their absorption through the skin and activity of the compound. Treatment of the skin prior to application of the topical steroid may also affect the absorption of the compounds into the skin. Treatments with keratolytics or with fat solvents (such as acetone) disrupt the epidermal barrier and increase penetration. Hydrating the skin has also been shown to increase the penetration of the corticosteroids. [0003] Once absor...

Claims

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Application Information

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IPC IPC(8): A61K31/573
CPCA61K9/0014A61K31/573A61K9/06A61P17/04A61P17/06A61P17/08
Inventor PLOTT, R. TODD
Owner MEDICIS PHARMA CORP
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